Failure is common in clinical trials since the successful failures presented in negative results always indicate the ways that should not be taken. In this paper, we proposed an automated approach to extracting positive and negative clinical research results by introducing a PICOE (Population, Intervention, Comparation, Outcome, and Effect) framework to represent randomized controlled trials (RCT) reports, where E indicates the effect between a specific I and O. We developed a pipeline to extract and assign the corresponding statistical effect to a specific I-O pair from natural language RCT reports. The extraction models achieved a high degree of accuracy for ICO and E descriptive words extraction through two rounds of training. By defining a threshold of p-value, we find in all Covid-19 related intervention-outcomes pairs with statistical tests, negative results account for nearly 40%. We believe that this observation is noteworthy since they are extracted from the published literature, in which there is an inherent risk of reporting bias, preferring to report positive results rather than negative results. We provided a tool to systematically understand the current level of clinical evidence by distinguishing negative results from the positive results.
翻译:在临床试验中,失败是常见的,因为以负面结果提出的成功失败总是表明不应采取的方法。在本文中,我们建议采用一种自动方法,通过引入一个PICOE(人口、干预、兼容、结果和效果)框架来提取正和负临床研究成果,以代表随机控制的试验(RCT)报告,E在其中表示特定I和O之间的效应。我们开发了一条管道,从自然语言RCT报告中提取相应的一对一对一对O的统计效果并将其分配给特定的一对I-O。提取模型通过两轮培训实现了ICO和E描述性词提取的高度准确性。我们通过界定P-价值的阈值,发现所有Covid-19相关的干预-结果配对的统计测试中,负结果占近40%。我们认为,这一观察值得注意,因为它们是从出版的文献中提取的,其中存在报告偏差的内在风险,宁愿报告正面结果而不是负面结果。我们提供了一种工具,通过区分正结果来系统理解目前的临床证据水平。